Immutep’s Trial Progress and Cash Burn Signal Critical 2025 Milestones Ahead

Pivotal Phase III Trial Milestone

Immutep Limited (ASX: IMM; NASDAQ: IMMP) marked a significant clinical milestone in Q3 FY25 by dosing the first patient in its pivotal TACTI-004 Phase III trial. This global study is evaluating eftilagimod alfa (efti), a novel MHC Class II agonist, in combination with Merck’s KEYTRUDA® and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to enrol approximately 756 patients across more than 150 sites worldwide, positioning Immutep at the forefront of immunotherapy innovation in one of oncology’s largest indications.

The TACTI-004 trial design was also showcased at the European Lung Cancer Congress (ELCC) 2025 in Paris, underscoring the company’s commitment to transparency and engagement with the oncology community. Immutep has selected a 30 mg dose of efti as the optimal biological dose based on encouraging data from earlier studies, including TACTI-002 and INSIGHT-003, which have demonstrated promising efficacy and safety profiles.

Progress Across Multiple Clinical Programs

Beyond TACTI-004, Immutep completed patient enrolment in several other key trials during the quarter. The EFTISARC-NEO Phase II trial, investigating efti combined with radiotherapy and KEYTRUDA® in resectable soft tissue sarcoma, reached its target enrolment of 40 patients. Similarly, the INSIGHT-003 Phase I trial, evaluating efti with KEYTRUDA® and chemotherapy in first-line non-squamous NSCLC, also completed enrolment with approximately 50 patients.

Immutep continues to monitor patient outcomes in the TACTI-003 Phase IIb trial for head and neck squamous cell carcinoma and the AIPAC-003 Phase II/III trial in metastatic breast cancer, with data maturation and regulatory engagement planned for later in 2025. These diverse programs highlight the company’s strategic focus on leveraging LAG-3 immunotherapy across multiple cancer types.

Financial Strength and Intellectual Property

Financially, Immutep reported a strong cash position of A$146.25 million at quarter-end, comprising cash, cash equivalents, and term deposits. This robust liquidity provides an expected cash runway through to the end of calendar year 2026, supporting ongoing clinical development and operational activities. The company’s disciplined cash management was reflected in a reduced R&D cash burn compared to the previous quarter, primarily due to completed enrolments and lower trial initiation costs.

On the intellectual property front, Immutep secured new patents for its LAG525 compound in the United States and the Philippines, as well as a Russian patent related to an assay for IMP761 potency measurement. These patent grants strengthen Immutep’s proprietary position in the competitive immunotherapy landscape.

Looking Ahead

With multiple trials advancing and data readouts anticipated in 2025, Immutep is well positioned to potentially reshape treatment paradigms in oncology through its LAG-3 targeted therapies. The company’s collaborations with global partners, including Merck, and its expanding clinical footprint across 19 countries, underscore its growing influence in immuno-oncology.